Executive Director, Clinical Operations

Spyre Therapeutics

12h • $285,000 - $310,000 • Remote

About The Position

Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies. The Executive Director, Clinical Operations, provides strategic leadership and hands-on oversight of global clinical trials, ensuring delivery within agreed timelines and budgets and in accordance with quality standards and applicable regulatory requirements.

The role translates clinical development objectives into operational plans and leads trial execution from start-up through close-out. It oversees trial planning, enrollment, site engagement, CROs and vendors, budgets, risk mitigation, and operational readiness for key milestones. The Executive Director partners closely with Clinical Development and other functions, serves as a key contact for CROs and clinical investigators, and develops Clinical Operations personnel. Success requires sound judgment, accountability, and the ability to balance strategic leadership with hands-on execution in a growing biotechnology company.

Requirements

• Bachelor’s degree in a scientific, healthcare, or related discipline.
• At least 10 years of global clinical research experience in the pharmaceutical or biotechnology industry.
• Demonstrated success overseeing clinical trial planning, start-up, enrollment, monitoring, data cleaning, database lock, closeout, and reporting.
• Experience leading CROs and clinical service providers, including vendor selection, contract negotiation, governance, and performance management.
• Strong financial and operational management skills, including study budgeting, forecasting, resource planning, and risk management.
• Thorough understanding of Good Clinical Practice and applicable local and global clinical trial requirements.
• Experience supporting audits, regulatory inspections, and inspection readiness.
• Demonstrated ability to lead and develop Clinical Operations personnel and guide cross-functional teams through influence.
• Excellent communication, interpersonal, and decision-making skills, including clear communication of complex issues and recommendations to senior leadership.
• Ability to manage competing priorities, adapt to changing needs, and combine strategic thinking with hands-on execution.

Nice To Haves

• Advanced degree.
• Late-stage dermatology clinical trial experience.
• Experience contributing to protocols, SOPs, clinical study reports, and regulatory submissions.

Responsibilities

• Lead clinical operational strategies and study plans aligned with clinical development priorities and corporate objectives; oversee global trials from feasibility and start-up through enrollment, conduct, database lock, and closeout.
• Establish and manage trial timelines, budgets, resource plans, and performance metrics; identify risks, develop mitigation plans, and resolve issues promptly.
• Partner with Clinical Development and cross-functional colleagues to assess protocol feasibility and provide operational input on protocols, informed consent forms, study plans, and other trial documents.
• Implement and manage clinical operational plans and programs to meet corporate goals and objectives.
• Lead CRO and vendor selection, contracting, governance, and performance oversight, ensuring clear responsibilities, communication, and accountability.
• Oversee country and site feasibility, selection, activation, monitoring, and closeout.
• Build relationships with clinical investigators and site teams to support trial execution, recruitment and retention, and issue resolution.
• Develop enrollment strategies with Medical Affairs, monitor recruitment performance, and address enrollment challenges.
• Partner with Data Management, Biometrics, Clinical Development, and other functions to support data quality, query resolution, database lock, and trial reporting.
• Develop and manage study budgets; oversee contract and budget negotiations and monitor forecasts, invoices, and payments with Finance and Legal.
• Partner with Quality to maintain inspection readiness, support audits and regulatory inspections, and resolve findings and implement corrective actions.
• Develop and maintain Clinical Operations SOPs, processes, and tools; provide training and drive quality and efficiency improvements.
• Provide senior leadership and Development Teams with updates on study progress, budget performance, risks, and decisions requiring escalation.
• Lead, mentor, and develop Clinical Operations personnel, setting clear expectations and fostering collaboration, ownership, and high-quality execution.
• Maintain current knowledge of relevant therapeutic areas, clinical trial practices, and regulatory requirements.
• Present regularly to senior staff and participate in relevant Development Team meetings.
• Stay familiar with developments in studied disease indications and applicable clinical trial guidelines and regulations.
• Attend scientific and external training meetings as needed.
• Perform other clinical operations activities as required.

Benefits

• Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, and health, welfare, and retirement benefits.
• Unlimited PTO.
• Two one-week company-wide shutdowns each year.
• Professional development opportunities.
• Remote working environment with frequent in-person meetings.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive